U-DECIDE: The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Sociodemographic characteristics of patients treated through the Affiliate network
研究概览
简要总结
The focus of this study is to learn about the factors that parents consider when making a decision for their child to participate or not in a clinical treatment research study.
详细描述
Aim 1:
- To describe the sociodemographic characteristics of patients treated through the Affiliate network, including those that are eligible for a therapeutic treatment study as well as those that are not. This aim will be accomplished using a survey based on previously validated tools measuring demographics, social determinants of health, and material hardship.
Following consent, the study team research assistant will verbally administer survey #1 to each participant or email the unique electronic link for each participant to complete. If necessary, survey #1 may be administered at a later date mutually agreed upon by the interviewer and the participant. Survey #1 contains questions on race, ethnicity, family structure, marital status, household income, and education level of parents, as well as previously validated instruments assessing cumulative hardship through assessments of housing, food accessibility, and utilities. Address information on both participants and non-participants will also be collected.
Aim 2:
- To examine the associations between social determinants, decision-making factors, trial-related attitudes, and additional individual preferences among parents/LARs of newly diagnosed pediatric oncology patients in the Affiliate network and the decision to enroll or not enroll on a therapeutic clinical trial. This aim will be accomplished through a convergent mixed-method design and include an additional exploratory qualitative sub-aim assessing potential differences in interviews conducted by parent versus non-parent interviewers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All English or Spanish speaking parents/LARs of patients 0-18 years of age with newly diagnosed cancer in the Affiliate network.
排除标准
- •Parents of children with relapsed or recurrent disease, or those with benign neoplasms.
结局指标
主要结局
Sociodemographic characteristics of patients treated through the Affiliate network
时间窗: Day 1, or during a future contact (approximately 1 month)
Sociodemographic information will be analyzed descriptively. Full home address data will be geocoded to generate area deprivation information for each participant. Cumulative hardship will be calculated using previously established measures and scoring.These scores will be analyzed descriptively. Exploratory comparative analysis will be done to determine if there are differences between the sub-group of patients eligible for clinical trial enrollment versus those who are not eligible.
The correlation between social determinants and individual preferences among parents/LARs and the decision to enroll on a therapeutic clinical trial.
时间窗: Day 1, or during a future contact (approximately 2 months)
Data collected from survey #1 for this subgroup of patients will be used to statistically describe the sociodemographic information for patients who are eligible to enroll on a clinical trial and comparative analysis will be conducted to examine differences and potential associations between the group of parents/LARs who do enroll their child on a clinical trial, and those who do not. Responses from survey #2 will be analyzed descriptively to provide an overall understanding of decision-making preferences and roles, as well as clinical trial attitudes amongst parents/LARs whose children are eligible for a clinical trial. Comparative analysis will be used to determine if there are differences in these individual preference items between the group of parents/LARs whose children do enroll on a clinical trial, and those who do not.
The correlation between social determinants, decision-making factors, trial related attitudes among parents/LARs and the decision to enroll or not enroll on a therapeutic clinical trial.
时间窗: Approximately 3 months after enrollment
Qualitative data from semi-structured interviews will be transcribed and formally analyzed using thematic content analysis.
Differences between parent/LAR individual preferences as expressed to parent interviewers compared to non-parent interviewers
时间窗: Approximately 3 months after enrollment
Qualitative data will be formally analyzed using thematic content analysis comparing data collected by parent interviewers to data collected by non-parent interviewers.
Acceptability of a parent navigator program in the Affiliate network
时间窗: After initiation of the Parent Navigator Program approximately 4 years after start of study
Acceptability: we will determine that the navigator program is acceptable if the median score on the acceptability scale is \> 3. Likert scale 1-5 will be used (1=Completely disagree, 2=Disagree, 3=Neither, 4=Agree, 5=Completely agree)
Feasibility of a parent navigator program in the Affiliate network
时间窗: After initiation of the Parent Navigator Program approximately 4 years after start of study
Feasibility: we will determine that the navigator program is feasible if the median score on the feasibility scale is \> 3. Likert scale 1-5 will be used (1=Completely disagree, 2=Disagree, 3=Neither, 4=Agree, 5=Completely agree)
Sociodemographic characteristics of patients treated through the Affiliate network
时间窗: Day 1, or during a future contact (approximately 1 month)
Sociodemographic information will be analyzed descriptively. Full home address data will be geocoded to generate area deprivation information for each participant. Cumulative hardship will be calculated using previously established measures and scoring.These scores will be analyzed descriptively. Exploratory comparative analysis will be done to determine if there are differences between the sub-group of patients eligible for clinical trial enrollment versus those who are not eligible.
The correlation between social determinants and individual preferences among parents/LARs and the decision to enroll on a therapeutic clinical trial.
时间窗: Day 1, or during a future contact (approximately 2 months)
Data collected from survey #1 for this subgroup of patients will be used to statistically describe the sociodemographic information for patients who are eligible to enroll on a clinical trial and comparative analysis will be conducted to examine differences and potential associations between the group of parents/LARs who do enroll their child on a clinical trial, and those who do not. Responses from survey #2 will be analyzed descriptively to provide an overall understanding of decision-making preferences and roles, as well as clinical trial attitudes amongst parents/LARs whose children are eligible for a clinical trial. Comparative analysis will be used to determine if there are differences in these individual preference items between the group of parents/LARs whose children do enroll on a clinical trial, and those who do not.
The correlation between social determinants, decision-making factors, trial related attitudes among parents/LARs and the decision to enroll or not enroll on a therapeutic clinical trial.
时间窗: Approximately 3 months after enrollment
Qualitative data from semi-structured interviews will be transcribed and formally analyzed using thematic content analysis.
Differences between parent/LAR individual preferences as expressed to parent interviewers compared to non-parent interviewers
时间窗: Approximately 3 months after enrollment
Qualitative data will be formally analyzed using thematic content analysis comparing data collected by parent interviewers to data collected by non-parent interviewers.
次要结局
未报告次要终点